LAMOTRIGINE

Product NDC: 69097-148
Requested package NDC: 69097-148-07
11-digit product format: 690970148
Labeler code: 69097
Product ID: 69097-148_60f518f2-5321-454d-aef0-49b3b3f8a36d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine
Dosage form: TABLET
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA077783
Marketing category: ANDA
Marketing start: 2010-11-01
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 25 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69097-148	69097-148-07	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077783-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01
A077783-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01
A077783-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01
A077783-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-001	LAMOTRIGINE	25MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-002	LAMOTRIGINE	100MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-003	LAMOTRIGINE	150MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077783-004	LAMOTRIGINE	200MG	TABLET / ORAL	2010-11-01	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077783-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077783-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077783-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077783-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077783-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077783-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077783-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077783-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077783-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077783-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077783-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077783-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077783-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077783-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077783-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077783-004	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
14a9502b-3d70-0496-a7e1-b16edaa005b8	Product name	5	20250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0	Product name	7	20250401
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-148-07	EA - Each	69097-148	df899197-1a05-43ac-862a-2117afab2f8a	1	2015-04-03
69097-148-12	EA - Each	69097-148	1e1e15c2-1a6c-4468-a32f-243625c980af	1	2015-04-03
69097-148-15	EA - Each	69097-148	08766069-4f40-4a6b-80b9-856378f9259f	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE TABLET [CIPLA USA INC.]	4
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE TABLET [CIPLA USA INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE TABLET [CIPLA USA INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LAMOTRIGINE TABLET [CIPLA USA INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LAMOTRIGINE TABLET [CIPLA USA INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LAMOTRIGINE TABLET [CIPLA USA INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LAMOTRIGINE TABLET [CIPLA USA INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LAMOTRIGINE TABLET [CIPLA USA INC.]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LAMOTRIGINE TABLET [CIPLA USA INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LAMOTRIGINE TABLET [CIPLA USA INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-148	LAMOTRIGINE TABLET [CIPLA USA INC.]	15	Legacy NDC	20201007_ecfa700a-117e-44fc-90c9-bd96b46763cd.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3H27498KS	LAMOTRIGINE	84057-84-1	LAMOTRIGINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198427	lamoTRIgine 100 MG Oral Tablet	PSN	bcdb72e2-6f06-492e-9968-26d372b96aeb	6
282401	lamoTRIgine 25 MG Oral Tablet	PSN	bcdb72e2-6f06-492e-9968-26d372b96aeb	6
198427	lamotrigine 100 MG Oral Tablet	SCD	bcdb72e2-6f06-492e-9968-26d372b96aeb	6
282401	lamotrigine 25 MG Oral Tablet	SCD	bcdb72e2-6f06-492e-9968-26d372b96aeb	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-148-07	69097014807	100 TABLET in 1 BOTTLE (69097-148-07)	100 tablet	2010-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LAMOTRIGINE	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	6
LAMOTRIGINE	Cipla USA Inc. \| Cipla Ltd.- Goa \| Cipla Limited, Bangalore \| Cipla Kurkumbh	2020-09-28	HUMAN PRESCRIPTION DRUG LABEL	15
LAMOTRIGINE	Clinical Solutions Wholesale, LLC	2020-09-25	HUMAN PRESCRIPTION DRUG LABEL	4
LAMOTRIGINE	Preferred Pharmaceuticals Inc.	2019-10-11	HUMAN PRESCRIPTION DRUG LABEL	2
LAMOTRIGINE	REMEDYREPACK INC.	2019-09-30	HUMAN PRESCRIPTION DRUG LABEL	3
LAMOTRIGINE	A-S Medication Solutions	2019-04-26	HUMAN PRESCRIPTION DRUG LABEL	14
LAMOTRIGINE	St. Mary's Medical Park Pharmacy \| Cipla Ltd.- Goa \| Cipla Limited, Bangalore	2018-11-15	HUMAN PRESCRIPTION DRUG LABEL	4